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510(k) Data Aggregation
K Number
K161865Device Name
iSage Rx (iSage Rx Basal Insulin Titration)
Manufacturer
iSag Rx, Inc.
Date Cleared
2017-03-07
(243 days)
Product Code
NDC
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
iSag Rx, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
iSage Rx™ (iSage Rx Basal Insulin Titration) is software indicated for use by adult patients aged 21 and above who have type 2 diabetes and their healthcare providers to titrate basal insulin. iSage Rx is not intended to replace the care and management provided by a healthcare professional trained in the management of diabetes. iSage Rx should not be used by patients with type 2 diabetes who are also using prandial insulin or patients with type 1 diabetes, or patients using an insulin pump.
Device Description
iSage Rx™ (iSage Rx Basal Insulin Titration) is software
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